HeartFlow Inc. announced that Health Care Service Corp. (HCSC), which operates Blue Cross and Blue Shield plans in five states, has issued a medical policy for the HeartFlow FFRct Analysis, a non-invasive technology that helps clinicians diagnose and treat patients with suspected coronary artery disease (CAD). HCSC — which operates Blue Cross Blue Shield plans in Illinois, Montana, New Mexico, Oklahoma and Texas — has determined that the use of noninvasive fractional flow reserve (FFR) following a positive coronary computed tomography (CT) angiogram may be considered medically necessary to guide decisions about the use of invasive coronary angiography in patients with stable chest pain at intermediate risk of CAD.

Philips recently announced that it acquired VitalHealth, a provider of cloud-based population health management solutions for the delivery of personalized care outside of the hospital, for example, in regional care networks. Headquartered in the Netherlands, VitalHealth’s products and services are being used by more than 100 healthcare networks in various countries including the United States, India, China, Sweden, Germany, Belgium and the Netherlands. The company was founded in 2006 by Mayo Clinic (U.S.) and Noaber Foundation (the Netherlands) and employs approximately 200 employees. Financial details of the transaction were not disclosed.

December 22, 2017 — To help streamline treatment of patients with heart failure and ensure the best possible patient outcomes, the American College of Cardiology published an expert consensus decision pathway for the optimization of treatment for patients with heart failure with reduced ejection fraction.

Essential Medical announced the completion of enrollment in the U.S. pivotal investigational device exemption (IDE) trial of the Manta large bore vascular closure device. The company said it has enrolled 341 patients at 21 different sites with 43 investigators in 10 months. Essential Medical President and CEO Greg Walters said the company expects to file a premarket approval (PMA) submission with the U.S. Food and Drug Administration (FDA) by the end of the first quarter in 2018.

December 21, 2017 — Bay Labs, a medical technology company applying artificial intelligence (AI) to cardiovascular imaging, recently announced it completed $5.5 million in financing. The Series A round was led by existing investor Khosla Ventures with participation from new investors including Data Collective (DCVC), Greenbox Venture Partners, Minneapolis Heart Institute Ventures and Georges Harik.

The Centers for Medicare & Medicaid Services (CMS) last week finalized the cancellation of the mandatory hip fracture and cardiac bundled payment models that were to be operated by the CMS Innovation Center and implemented changes to the Comprehensive Care for Joint Replacement (CJR) Model. These changes will offer greater flexibility and choice for hospitals in providing care to Medicare patients.

Philips recently announced agreements with 3D Systems and Stratasys, two global leaders in the 3-D printing industry, to help progress patient care and improve the clinician experience. Advanced 3-D modeling provides radiologists with additional views to help strengthen anatomical knowledge which could enhance clinical impact in reviewing complex, multi-disciplinary cases.

A team of researchers at the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, U.K., has been awarded €6.5 million from the Horizon 2020 European Commission fund. The team — a partnership between Leicester’s Hospitals, the University of Leicester and Loughborough University, and led by clinical scientist consultant Prof. Anthony Gershlick from the university’s Department of Cardiovascular Sciences — will investigate the impact of using extracorporeal membrane oxygenation (ECMO) on the outcomes of patients who have had a severe heart attack.

ERT recently announced it has acquired iCardiac Technologies, a provider of centralized cardiac safety and respiratory solutions that accelerate clinical research. Financial terms of the transaction were not disclosed.


As payers and other healthcare entities look to better manage costs, especially in the acute care setting, it is important to note that there are some clinical areas where the hospital’s margins are already modest and shrinking. For example, in a typical pulmonary vein isolation case, the cost of devices alone exceeds $10,000. This does not include additional capital equipment costs, software costs, pharmaceuticals, clinical staffing and ancillary equipment or any hospital overhead.


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